ExaMD Inc. (Headquarters: Minato-ku, Tokyo; Representative Director: Yasushi Hama, hereinafter ExaMD), a group company of ExaWizards Inc. (Minato-ku, Tokyo; President and CEO: Makoto Haruta), has commenced clinical development for its Conversational Voice Dementia AI Diagnostic Support App (hereinafter "the Product"), which evaluates cognitive function using proprietary AI from free conversation voice, for home use under a doctor's prescription. The product, currently in clinical trials*2 as a Software as a Medical Device (SaMD) for diagnostic support, would be the first in Japan*1 if approved for home use. The company aims for early approval of the Product, including for home use. ☑ Background MCI (Mild Cognitive Impairment), the stage before dementia, is not yet dementia, and it is possible to maintain or improve cognitive function through appropriate intervention while continuing daily life. Noticing MCI at this stage is a critical turning point that significantly impacts one's future life. Early detection allows for the suppression of progression not only through pharmacotherapy but also non-pharmacological treatments. Furthermore, as it is not yet dementia, the individual's wishes can be widely reflected, including in various contractual matters. However, in Japan, most people are not aware they are in the MCI stage. While the number of people with dementia and MCI combined is estimated to be around 10 million*3 in Japan, cognitive function tests necessary for their detection are performed only about 900,000 times*4 annually. With a low detection rate of MCI at around 6-15%*5, many cases are not detected and are only discovered after progression. This is due to the burden of hospital visits and psychological stress of testing for patients, as well as the significant burden on medical institutions to conduct cognitive function tests. Moreover, existing simple tests (e.g., MMSE) have significant variability in sensitivity for MCI, with some reports indicating a d